J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the […]
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Tidepool Pancreas App Wins FDA Approval
The US Food and Drug Administration (FDA) has approved the Tidepool “artificial pancreas” app. The prescription-only software connects continuous glucose monitors (CGMs) and insulin pumps to automate insulin delivery and blood sugar management in patients with Type I diabetes. The app will work with […]
Using the UK’s Innovative Medicines Fund to Accelerate Rare Disease Drug Development and Access
The UK’s Innovative Medicines Fund (IMF) was started in collaboration with the NHS England and National Institute for Health and Care Excellence (NICE) to provide novel medicines with unresolved uncertainties to patients with rare non-cancer diseases that have little treatment options. In doing so, […]
US Senators Blast Moderna for COVID Vaccine Price Hikes
Moderna is drawing heat from some US lawmakers and political leaders over its plans to spike prices of its COVID-19 vaccine to $110-130 per shot. The planned price hike, which is higher than the original price increases floated last fall, was lambasted by senators like Bernie Sanders (I-VT), […]
EMA Committee Announces Orphan Drug Application Changes to Improve Access to Rare Eye Disease Medications
Policies regarding orphan drug designations for a group of rare genetic eye diseases called inherited retinal dystrophies are changing, according to the European Medicines Agency (EMA). The changes would target terminology regarding the categories of disorders that are covered under the orphan drug […]
US Sen. Warren Calls for March-In Rights for Prostate Cancer Drug
Elizabeth Warren (D-MA) and 25 other US senators wrote a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting that the agency implements march-in rights for Astellas’ and Pfizer’s prostate cancer drug Xtandi. This would allow the federal government to take […]
Sonoma Pharma Seals Pricing and Distribution Arrangement, Spiking Share Prices
Sonoma Pharmaceuticals has announced that it has locked in a distribution and pricing deal with the Defense Logistics Agency. The announcement of the deal, which covers its Microcyn Rx products, was followed by Sonoma’s shares jumping in price by 82%. Products included in the deal are used for wound […]
Millions of Medicaid Beneficiaries Likely to Lose Coverage When Continuous Enrollment Ends
Medicaid enrollees must reapply every year in a complicated process fraught with hidden pitfalls that could sink one’s coverage. This process was suspended during the pandemic, but the provision’s end date of March 31st is fast approaching. As a result, millions of beneficiaries are set to lose […]
Talking Real-World Evidence with Healthcore’s Co-Founders Mark Cziraky and Marcus Wilson
As Healthcore gears up for their impending brand transition to Carelon Research in the coming months, co-founders Mark Cziraky and Marcus Wilson discussed their insights into the importance of high-quality real-world evidence (RWE) generation methods and why they founded the company. […]
New Venture Capital Firm Launches to Support Health Sciences Digitization
Cutting edge technology like big data analytics, artificial intelligence, and machine learning are poised to revolutionize life sciences and healthcare. Dimension, a new venture capital fund, has launched today in to support the digitization of life sciences. The fund is prepared to support new […]
